“We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency,” FDA Commissioner Marty Makary said in a statement.
The vouchers don’t guarantee approval, but instead mean that regulators will try to shorten their reviews from a period of months to weeks.
In a separate move, the FDA authorized initial testing of a drug related to ibogaine, a powerful psychedelic made from an African shrub, for people with alcohol use disorder. Ibogaine is known to sometimes cause dangerous heart rhythms but has been embraced by combat veterans as a way to treat trauma and addiction.
The drugmaker, DemeRx, is led by a Florida-based researcher who first began studying ibogaine as a treatment for cocaine addiction in the 1990s, before federal health officials pulled funding for the work.
“Every grant proposal that I submitted to (the National Institute on Drug Abuse) was rejected,” Deborah Mash, a neurologist and founder of DemeRx, told The Associated Press. “I couldn’t get that funding and that’s why ibogaine didn’t advance in the 1990s.”
Ibogaine is known to cause intense hallucinations, nausea, vomiting, tremors and sometimes dangerous irregular heart rhythms. Mash says DemeRx’s drug is a metabolite of ibogaine, and doesn’t carry the same hallucinogenic effects or risks as the original drug.
Saturday’s White House event on psychedelics suggested Trump’s political allies had a role in pushing the drugs to the top of his agenda.
On his show earlier this week, Rogan said he learned about ibogaine from his friend Ed Clay, a mixed martial arts trainer and entrepreneur who runs retreats making use of it in Mexico.
Virtually all psychedelics, including LSD, psilocybin and MDMA are classified as Schedule I substances, a category for high-risk drugs that have no medically accepted use.
For decades, drugmakers steered clear of the substances due to the difficulties of studying drugs that are illegal under federal law.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
